510(k) K141437 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
XLR8 PLUS (XLR8+)
| Applicant | Genadyne Biotechnologies, Inc., Hicksville NY, US |
| Decision | Substantially Equivalent, Sep 19, 2014 |
| Received | May 30, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141437
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.